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FDA 510(k)

EnteraLoc Flow

K-Number: K210971 · 2021-08-18

ApplicantVonco Products
Decision Date2021-08-18
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EnteraLoc Flow is the device name listed in this FDA 510(k) record. The listed applicant is Vonco Products. It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K210971. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnteraLoc Flow?

EnteraLoc Flow is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is Vonco Products. The 510(k) number is K210971.

When did EnteraLoc Flow receive FDA 510(k) clearance?

EnteraLoc Flow received FDA 510(k) clearance on 2021-08-18, under 510(k) number K210971.

Who is the listed applicant for EnteraLoc Flow?

The FDA 510(k) record lists Vonco Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnteraLoc Flow?

The FDA product code for EnteraLoc Flow is PIF.

Other records listing Vonco Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223683EnteraLoc Flow

Related Devices (Code: PIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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